Genetic engineering peptide drugs is genetic engineering technology into the practical application of one of the fastest results, peptide drugs, including peptide hormones, cell growth factors, lymphokines, coagulation factors and enzymes. During the period of the 8th and 9th Five-Year Plan, through the efforts of the relevant scientific and technological personnel in China, the research and development of genetically engineered drugs has a better foundation and initially formed a certain industrial base, but there are fewer innovative projects with independent intellectual property rights, and the problem of duplicated research and production is more serious. Therefore, during the "Tenth Five-Year Plan" period, priority will be given to supporting innovative projects, and according to the morbidity rate in China, we will focus on supporting the following major diseases in genetic engineering therapeutic drugs:
(1) cardio-cerebral and cerebral vascular disease therapeutic drugs
(2) anti-tumor drugs
(3) neuropsychiatric disease therapeutic drugs
(4) Anti-virus and other serious infectious disease drugs
2, genetic engineering vaccines
Genetic engineering vaccines have played an important role in preventing diseases that seriously jeopardize the lives and health of human beings. In recent years, China's research and development of genetic engineering vaccines is developing rapidly, there have been genetically engineered hepatitis B, dysentery, cholera vaccine has been successfully developed. There are still a variety of genetically engineered vaccines in the development stage. Key support:
(1) genetically engineered anti-bacterial infection vaccine
(2) genetically engineered anti-viral infection vaccine
(3) genetically engineered anti-parasite infection vaccine
(4) therapeutic vaccine
(5) nucleic acid vaccine
3, nucleic acid drugs and antisense nucleic acid drugs
Oligonucleotide Drugs are oligonucleotides with a specialized order for blocking the expression of harmful genes. They are characterized by high specificity. The main ones developed at present are antisense nucleic acids, peptide nucleic acids and nucleases. More than 60 varieties of nucleic acid-based drugs have been developed abroad. Antisense nucleic acids for the treatment of cytomegalovirus retinitis have been approved for marketing. There are also more than 10 kinds of nucleic acid drugs are undergoing clinical trials. China's research on nucleic acid drugs has a better foundation, should support the better prospects for therapeutic drugs, to promote the completion of clinical research as soon as possible, and put on the market at an early date.
4, therapeutic agents
Gene therapy is a new field of research in contemporary medicine and biology, which tries to regulate the expression of defective genes in the cells from the gene level or correct and replace defective genes with normal genes to achieve the treatment of genetic defects caused by genetic disorders, immune deficiencies, and tumors due to the activation of oncogenes or inactivation of cancer suppressor genes and other diseases, that is, gene-related diseases. Diseases. Broadly speaking, gene therapy is the introduction of expressible genes with normal functions into the target cells, so as to correct the genetic diseases caused by gene defects. In recent years, China has made some progress in gene therapy for malignant tumors, cardiovascular diseases, neurological diseases, and the key technologies and products of gene therapy, but the overall level is quite different from the international level. Key support:
(1) gene therapy products for malignant tumors
(2) gene therapy products for hereditary diseases
(3) gene therapy products for neurological diseases
(4) gene therapy products for cardiovascular diseases
5. Monoclonal antibodies and genetically engineered antibodies
Monoclonal antibodies and genetically engineered antibodies have broad applications and markets. Antibodies have a wide range of uses and markets, more than 500 kinds of therapeutic and diagnostic antibodies have been put on the market in the international arena, and dozens of products have been approved for marketing in China, but the scale is relatively small and the varieties are incomplete, therefore, during the Tenth Five-Year Plan period, the focus will be on supporting:
(1) new diagnostic reagents and kits for monoclonal antibodies
(2) new enzyme-linked diagnostic reagents and kits(3) humanized genetically engineered antibody therapeutic agents
6, diagnostic reagents
Immuno-diagnostic reagents is the use of labeled tracer substances on the combination of antigens and antibodies to each other for diagnosis of the specific reaction, its application is very wide range, can be
To determine the endocrine hormones, proteins, peptides, nucleic acids, neurotransmitters, cell surface antibodies and other biological parameters.
It can be used to measure endocrine hormones, proteins, peptides, nucleic acids, neurotransmitters, cell surface antigens and other active biological substances. Currently, immunoassay kits include radioimmunoassay kits, enzyme immunoassay kits, chemiluminescence kits, and time-differentiation kits. During the "Tenth Five-Year Plan" period, we will focus on supporting new diagnostic reagents with high sensitivity and remarkable features, as well as new diagnostic reagents for which no diagnostic methods are currently available.
7, DNA probes and gene diagnostic reagents
8, biochip system
Biochip is an epoch-making micro-analysis technology developed in the mid-1990s, which is a hot topic in the world of research and development; focus on the support of:
(1) DNA sequence analysis
(2) genetic diseases and tumor diagnosis
(1) DNA sequence analysis
(2) genetic diseases and tumor diagnosis
(2) genetic diseases and tumor diagnostic
(2) genetic diseases and tumor diagnostic Diagnosis of genetic diseases and tumors
(3) Diagnosis of infectious diseases
(4) Development of new drugs and component screening
9, new pharmaceutical thrombolytic enzymes and preparations
10, new active proteins and peptides
11, pharmaceutical amino acids
currently, medical amino acid I.V. supporting the need for imported species;
12, new antibiotics
The use of modern biotechnology, the design and transformation of the original antibiotic nature and the current antibiotic treatment of the problems that exist, to create a more clinically applicable or have a brand-new therapeutic effect of the antibiotics;
13, genetically modified animals, plants, pharmaceutical engineering products
The use of genetically modified animals, plants, bio-reactors to produce genetic drugs is a A brand-new production mode, compared with the previous pharmaceutical technology, has an incomparable superiority, should be given support;
14, tissue engineering products
In the past few decades, the world can be used as a transplantation of the number of organs is very lack of, the development of tissue engineering, will greatly alleviate these problems. Currently, the first to support some of the building block materials in tissue engineering, such as extracellular matrix, biodegradable polymers, etc.;
15, biotechnology development of natural medicines
China's research and application of traditional Chinese medicine has a traditional advantage in the prevention of disease and treatment of diseases, especially difficult and complicated diseases show a unique advantage. In order to promote the modernization of traditional Chinese medicine, the use of new technologies to develop biological resources and traditional Chinese medicine resources has become an extremely important work; focus on supporting:
(1) large-scale culture of plant and animal cell production technology and products
(2) fermentation method to produce valuable, scarce medicinal raw materials
(3) animal and plant tissues to isolate and extract biologically active substances raw materials and new drugs
(4) natural extracts of active substances and new medicines >(4) natural extraction of active substances of chemical modification products and new drugs
16, marine biological active substances and drugs
The use of biochemical engineering and other modern biotechnology, the development of marine biological resources is an emerging industry in the pharmaceutical industry. China's rich marine resources, available for research and development of more varieties, for the treatment of cardiovascular and cerebrovascular diseases, tumors, kidney disease, viral hepatitis and other major diseases of the development of new drugs of marine organisms to provide the conditions; focus on supporting:
(1) anti-cardiovascular and cerebrovascular disease of marine organisms of the new drugs
(2) antiviral marine organisms of the new drugs
(3) a variety of marine organisms of the bio-active substance Raw materials and new drugs
17, new high-efficiency enzyme preparations
China's research in enzyme engineering and related technologies is close to the international level, and there is a strong strength in large-scale production, but the supporting capacity of upstream and downstream engineering technology is poor. By increasing new varieties of enzyme preparations and expanding new applications, it is an important way to develop enzyme preparations for product restructuring;
18, biological separation technology devices and related reagents
Biotechnology products, separation and purification technology for the quality of the product, the yield and the cost of the increasingly important role. In the traditional fermentation industry, which is dominated by small molecule products, the cost of separation accounts for about 60% of the total cost, while the cost of separation and purification is as high as 90% in modern genetic engineering products. Therefore, separation and purification technology plays a very important role in product industrialization. China's pharmaceuticals, natural medicines, fermentation products, biological products and genetic engineering products in the demand for separation media amounted to about 3,000 tons per year, high-performance separation media are mainly dependent on imports. In order to reverse this situation, measures must be taken to obtain support from various parties;
Currently, China has a variety of separation media synthesis capabilities and processes, there are a number of quality to meet or close to the imported products of the media, but the production capacity is low. Therefore, suitable for genetic engineering, cell engineering, fermentation engineering, the production of natural medicines, active ingredients of traditional Chinese medicine and other separation of high-precision, automated, programmable, continuous and efficient equipment and media, such as macroporous resins and other production equipment suitable for biopharmaceutical companies, is currently an urgent need to solve the problem of industrialization. In addition, a large number of supporting reagents and kits are needed in biotechnology research, development and production, and 80% of the reagents need to be imported at present, so attention should be paid to them. Key support:
(1) the development and production of new high-efficiency separation media and devices for biological and pharmaceutical applications
(2) the development and production of new high-efficiency membrane separation components and devices for biological and pharmaceutical applications
(3) the development and production of new high-efficiency chromatography media and devices for biological and pharmaceutical applications
(4) the development and production of preparative electrophoretic separation technology and devices and production
(5) biological, pharmaceutical research, production of reagents, reagent kits development and production
19, biosensors
Biosensors are widely used in the pharmaceutical industry, the food fermentation industry, clinical care and other fields, the market has great potential. China's domestic development of sensor varieties, unstable performance, has not yet formed a large number of production capacity, can not meet market demand
; focus on supporting:
(1) medical, pharmaceutical, scientific research with biosensors
(2) dialysis biochemical parameters of the joint detection, geriatric disease joint detection of sensors and other multifunctional clinical diagnostic sensors
(3) On-line optimization control system for fermentation industrial processes such as amino acids and antibiotics, and on-line monitoring system for multi-parameter biosensors